TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

K133897 · Infraredx, Inc. · OGZ · Apr 23, 2014 · Cardiovascular

Device Facts

• Record ID: K133897
• Device Name: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Apr 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Story

TVC Imaging System combines near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) to examine coronary arteries. Device uses TVC Insight Catheter to acquire NIRS and IVUS data simultaneously during invasive coronary angiography. System processes signals to detect lipid-core-containing plaques and assess lipid core burden; provides ultrasound imaging of coronary pathology. Used in clinical settings by physicians (interventional cardiologists) during catheterization procedures. Output displayed on system monitor; assists clinicians in identifying lipid-rich plaques and assessing vessel morphology to guide interventional decision-making. Benefits include improved characterization of coronary artery disease beyond standard angiography.

Technological Characteristics

System integrates NIRS and IVUS modalities. Employs TVC Insight Catheter for intravascular data acquisition. NIRS utilizes near-infrared light for lipid core detection; IVUS utilizes ultrasound transducers for structural imaging. Connectivity includes standard medical imaging interfaces. Software-based signal processing for co-registered NIRS/IVUS display.

Indications for Use

Indicated for patients undergoing invasive coronary angiography or candidates for transluminal coronary interventional procedures requiring near-infrared examination of coronary arteries for lipid-core-containing plaque detection/burden assessment and intravascular ultrasound imaging of coronary pathology.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Infraredx TVC Imaging System (K113338)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

April 23, 2014

Infraredx, Inc. Steven Chartier Vice President Operations, Quality and Regulatory 34 Third Ave. Burlington, MA 01803

Re: K133897

> Trade/Device Name: TVC Imaging System, TVC Insight Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OGZ, OBJ Dated: March 28, 2014 Received: March 31, 2014

Dear Steven Chartier.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Steven Chartier

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Infraredx 7VC Imaging System

Premarket Notification Traditional 510(k)

## Section 4

## Indications for Use

510(k) Number (if known): K1333897

Device Name: TVC Imaging System™

Indications for Use:

- 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
- a. The System is intended for the detection of lipid-core-containing plaques of interest.
- The System is intended for the assessment of coronary artery lipid core b. burden.
- 2. The System is intended for ultrasound examination of coronary intravascular pathology.
- a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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